Methotrexate, Leflunomide Combination Effective for Rheumatoid Arthritis

November 4, 2000

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PHILADELPHIA (Reuters Health) Nov 3 - Methotrexate combined with leflunomide

seems to have a synergistic effect in relieving rheumatoid arthritis (RA)

symptoms, Dr. M. Kremer reported at the meeting of the American College of

Rheumatology.

" It's a new era, where we're recognizing that drugs often work better in

combination than alone, " Dr. Kremer, from the Center for Rheumatology, in

Albany, New York said. " Leflunomide [and methotrexate] have been given alone and

studied alone, and they are efficacious. But we're trying get an even better

level of response. "

Dr. Kremer and colleagues studied 263 patients with active RA who were failing

methotrexate therapy. They gave 130 patients methotrexate combined with 10

mg/day of leflunomide, while the remaining patients received methotrexate plus a

placebo.

After 24 weeks, the researchers found that 46% of patients in the leflunomide

group responded to the combination therapy, compared with only 20% in the group

receiving methotrexate alone. A response was defined as at least a 20%

improvement in the number of tender and swollen joints, plus at least a 20%

improvement in other areas such as the patient's or physician's assessment of

the disease or the intensity of RA-related pain.

Side effects of the combination therapy, which was generally well tolerated,

included diarrhea, nausea, and dizziness. Patients on the combination therapy

also had a greater degree of elevation of liver enzymes, but almost all the

patients returned to normal with adjustment of the medication, Dr. Kremer said.

The researchers plan to do a long-term followup study to see if these good

results hold, Dr. Kremer said. The current study was sponsored by Aventis, maker

of leflunomide.

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